Summary

for people ages 18 years and up (full criteria)
at UC Davis UCLA
study started
estimated completion

Description

Summary

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

Official Title

An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Keywords

Lung Diseases, Interstitial Lung Diseases Nintedanib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

You CAN'T join if...

  • Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
  • Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
  • Previous enrolment in this trial.

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • University of California Davis
    Sacramento California 95817 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boehringer Ingelheim
ID
NCT03820726
Phase
Phase 3
Study Type
Interventional
Last Updated